Medical Device Manufacturer · US , Boston , MA

Etiometry, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2015

Official Website

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Etiometry, Inc. Cardiovascular ✕

11 devices

1-11 of 11

Cleared Apr 03, 2026

Etiometry Platform

Cardiovascular · 106d

Cleared Feb 12, 2025

Etiometry Platform (DAV 5.4 RAE 9.2)

Cardiovascular · 264d

Cleared Jul 07, 2023

T3 Platform software

Cardiovascular · 219d

Cleared Jan 06, 2023

T3 Platform software

Cardiovascular · 443d

Cleared Jun 22, 2022

T3 Platform Software

Cardiovascular · 266d

Cleared Nov 25, 2020

T3 Platform software

Cardiovascular · 103d

Cleared Dec 08, 2019

T3 Platform software

Cardiovascular · 303d

Cleared May 26, 2017

Cardiovascular · 205d

Cleared Mar 31, 2016

Cardiovascular · 233d

Cleared Oct 29, 2015

Cardiovascular · 126d

Cleared Mar 04, 2015

Cardiovascular · 162d